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Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Deficit in Obese Children and Adolescents (Obevidos)

16. november 2022 oppdatert av: Hospices Civils de Lyon

Treatment of Vitamin D Deficit in Obese Children and Adolescents: a Multi-centre Open Label Randomized Controlled Study Comparing the Efficacy of Two Oral Supplementation Regimens: Monthly Boluses Versus Daily Doses for Correcting Blood Vitamin D Level. A French-Swiss Collaboration

Childhood obesity prevalence is increasing and is a serious public health challenge. Indeed, according to INPES in 2006, overweight and obesity were affecting 18 % of French children between 3 and 17 years. 3 % of the boys and 4 % of the girls were classified as obese. Obese children are likely to develop chronic disease, starting at paediatric age, as cardiovascular or bone diseases, or type 2 diabetes.

Vitamin D deficiency is recognized to play an essential role in bone metabolism and arterial hypertension and type 2 diabetes development.

Obesity, in adults like in children, is associated with vitamin D deficiency. Common explanations for this low serum concentration of 25(OH)D in obese are the sequestration and/or the volumetric dilution of this lipid-soluble vitamin by adipose tissue. Therefore, obese population is at higher risk of developing cardiovascular and metabolic complications.

The nutrition comity of French Pediatric Society (SFP) edit vitamin D supplementation recommendations (2012) for adolescents at risk of deficit: supplementation by trimestral loading dose of 80 000 to 100 000 UI of vitamin D. However, for obese patients, the deficit is difficult to cure with classical loading doses. It seems that these patients need higher dose of Vitamin D (two to three times higher). Likewise, the optimum scheme of administration (daily vs monthly) was never evaluated.

Given new physiopathological data on pleiotropic role of vitamin D (on bone, cardiovascular system, adipose tissue) and in light of consequence of obesity on these systems, it seems essential to obtain data on vitamin deficit correction in obese children and adolescents and to evaluate bone status of these patients using modern imaging technics (high resolution peripheral quantitative computed tomography, HRpQCT).

In this context, the OBEVIDOS study, randomised multi-centre prospective in 156 obese children and adolescent will allow us for :

  • evaluate vitamin D correction effect by two scheme of administration
  • establish an inventory of vitamin D status in this population
  • Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model
  • study, in a patient sub-group, the impact of vitamin D deficit and of obesity by itself on bone, by analysing bone micro-architecture

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

156

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Aged between 5 to 18 year-old
  • Being obese (BMI >97th percentile for age and gender using the WHO references)
  • Patients (parents) having given their informed consent
  • Patient having insurance from the national health system

Exclusion Criteria:

Children will be excluded from the study if:

  • They suffer from symptomatic vitamin D deficiency (tetany, muscular hypotonia, hypocalcaemic seizure) or present signs of rickets at the X-ray (osteopenia and cortical thinning of the long bones, stress fractures, and metaphyseal widening and fraying. The earliest rachitic change is a loss of demarcation between the metaphysic and growth plate and loss of the provisional zone of calcification). A 10-point radiographic scoring system will be used to assess the presence and the severity of rickets on the basis of knee and wrist findings.
  • They suffer from a chronic disease such as granulomatous conditions, Williams syndrome, or hypothyroidism predisposing to hypocalcaemia or in case of hypercalcaemia, liver/kidney disease, malabsorption diseases.
  • They are under treatment of anticonvulsivants/barbiturates or steroids which increase the catabolism of 25(OH)D.
  • Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product.
  • Pregnancy.
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
  • Previous enrolment into the current study

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Monthly bolus arm
Legemiddel: Monthly bolus of cholecalciferol per os
Bolus therapy (100'000 - 200'000 IU/month depending on age: < or ≥ 9 years old) for 3 months
Aktiv komparator: Daily arm
Legemiddel: Daily dose of cholecalciferol per os
Daily substitution (3'500 to 6'500 IU/day depending on age: < or ≥ 9 years old) for 3 months
Annen: Control group
Group of obese patients without vitamin D deficiency
Annen: Control
no cholecalciferol therapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients reaching the therapeutic target defined as vitamin D (25(OH)D) serum level ≥ 50 nmol/L and < 120 nmol/L
Tidsramme: Month 4
Month 4

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
calcium dosages
Tidsramme: Month 4
blood safety dosages
Month 4
phosphore dosages
Tidsramme: Month 4
blood safety dosages
Month 4
urinary calcium
Tidsramme: Month 4
urinary safety dosages
Month 4
creatinin
Tidsramme: Month 4
urinary safety dosages
Month 4
Treatment compliance
Tidsramme: Month 4
Month 4
Evaluation of influence of type of skin on study results
Tidsramme: Month 4
assessed by Fitzpatrick scale
Month 4
Evaluation of influence of sun exposure on study results
Tidsramme: Month 4
assessed by a questionnaire
Month 4
Evaluation of influence of physical activity on study results
Tidsramme: Month 4
assessed by a questionnaire
Month 4
Evaluation of influence of alimentary intakes on study results
Tidsramme: Month 4
assessed by questionnaires
Month 4
Modeling of vitamin D concentration
Tidsramme: Month 4
Modeling and simulation of vitamin D concentration in obese children and adolescents using a mathematical PBPK model
Month 4
Evaluation of one mineral density by biphotonic absorptiometry in the spine
Tidsramme: Day 1
Comparison of the both treated arms with the control group
Day 1
Evaluation of one mineral density by biphotonic absorptiometry in the femoral neck
Tidsramme: Day 1
Comparison of the both treated arms with the control group
Day 1
Evaluation of bone micro-architecture (HRpQCT) at the radius
Tidsramme: Day 1
Comparison of the both treated arms with the control group
Day 1
Evaluation of bone micro-architecture (HRpQCT) at the tibia
Tidsramme: Day 1
Comparison of the both treated arms with the control group
Day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospices Civils de Lyon

Etterforskere

  • Hovedetterforsker: Carine Villanueva, Hospices Civils De Lyon

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2023

Primær fullføring (Forventet)

1. april 2026

Studiet fullført (Forventet)

1. april 2026

Datoer for studieregistrering

Først innsendt

24. april 2018

Først innsendt som oppfylte QC-kriteriene

24. april 2018

Først lagt ut (Faktiske)

7. mai 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. november 2022

Sist bekreftet

1. november 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 69HCL18_0148

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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